Lamictal 25mg Tablets
WARNING: Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands. The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if you take valproic acid or divalproex sodium with this drug, if you start taking this drug at too high of a dose, or if your dose is raised too fast. Skin reactions have also happened without any of these. Talk with your doctor.Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor. @ COMMON USES: It is used to help control certain kinds of seizures.It is used to treat bipolar disorder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant; Mood Stabilizer
Pharmacologic Class
Phenyltriazine derivative; Voltage-gated sodium channel blocker
Pregnancy Category
Not available
FDA Approved
Dec 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamotrigine is a medication used to treat certain types of seizures (epilepsy) and to help prevent mood swings in people with bipolar disorder. It works by calming overactive nerve signals in the brain. It's very important to start this medication at a very low dose and increase it slowly over several weeks to reduce the risk of a serious skin rash.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter your dose or stop taking this medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dose to minimize the risk of side effects.
If you stop taking this medication and need to restart, your doctor may recommend starting at a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
Important Administration Instructions
Swallow the medication whole; do not chew, break, or crush it.
If you have difficulty swallowing, consult your doctor for guidance.
Do not alter your dose or stop taking this medication without consulting your doctor, as this may lead to seizures.
If you need to stop taking this medication, your doctor will instruct you on how to gradually taper off the dose to minimize the risk of side effects.
If you stop taking this medication and need to restart, your doctor may recommend starting at a lower dose and gradually increasing it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in a local drug take-back program.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take exactly as prescribed; do not stop taking it suddenly, as this can cause seizures to return or worsen.
- Follow the slow dose titration schedule carefully to minimize the risk of serious rash.
- Report any rash, fever, swollen glands, or mouth sores to your doctor immediately.
- Be aware that lamotrigine can cause dizziness, drowsiness, or blurred vision, especially when starting or changing doses. Avoid driving or operating machinery until you know how it affects you.
- Avoid or limit alcohol consumption, as it can increase side effects.
- If you are a woman of childbearing potential, discuss contraception with your doctor, as oral contraceptives can affect lamotrigine levels, and lamotrigine can affect oral contraceptive efficacy (though less common).
- Carry a medical alert card or wear a bracelet indicating you take lamotrigine.
Available Forms & Alternatives
Available Strengths:
- Lamictal 150mg Tablets
- Lamictal 200mg Tablets
- Lamictal 100mg Tablets
- Lamictal 25mg Tablets
- Lamictal 5mg Chewabl Disprsbl Tabs
- Lamictal 25mg Chewabl Disprsbl Tabs
- Lamictal Orange Strt Kit25mg/100mg
- Lamictal Blue Starter Kit 25mg
- Lamictal XR 25mg Tablets
- Lamictal XR 50mg Tablets
- Lamictal XR 100mg Tablets
- Lamictal XR 200mg Tablets
- Lamictal XR 25-50-100mg Titrtn Kit
- Lamictal XR 25-50mg Titration Kt 28
- Lamictal XR 50-100-200mg Titrtn Kit
- Lamictal ODT 25mg Tablets
- Lamictal ODT 50mg Tablets
- Lamictal ODT 100mg Tablets
- Lamictal ODT 200mg Tablets
- Lamictal ODT 25-50-100mg Tb Kt Orng
- Lamictal ODT 25-50mg Tb Kit Blue
- Lamictal ODT 50-100mg Tb Kit Green
- Lamictal Green Strt Kit 25mg/100mg
- Lamictal XR 300mg Tablets
- Lamictal XR 250mg Tablets
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized titration required. Initial dose typically 25 mg once daily for 2 weeks, then 50 mg once daily for 2 weeks, then increase by 50-100 mg/day every 1-2 weeks. Maintenance dose varies significantly based on indication and concomitant medications.
Dose Range:
100 - 700 mg
Condition-Specific Dosing:
Epilepsy (monotherapy):
25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then 100 mg daily for 1 week, then 200-400 mg daily (divided doses).
Epilepsy (with valproate):
25 mg every other day for 2 weeks, then 25 mg daily for 2 weeks, then 50 mg daily (divided doses). Maintenance 100-200 mg/day.
Epilepsy (with enzyme-inducing AEDs without valproate):
50 mg daily for 2 weeks, then 100 mg daily (divided doses) for 2 weeks, then 200 mg daily (divided doses) for 1 week. Maintenance 300-500 mg/day.
Bipolar I Disorder (maintenance):
25 mg daily for 2 weeks, then 50 mg daily for 2 weeks, then 100 mg daily for 1 week, then 200 mg daily. Target dose 200 mg/day, but some patients may require 100 mg/day or 300-400 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 2 years.
Child:
Dosing for children (2-12 years) is weight-based and depends on concomitant medications. Initial doses are very low (e.g., 0.3 mg/kg/day or 0.6 mg/kg/day) and titrated slowly. Max doses up to 15 mg/kg/day (max 400 mg/day).
Adolescent:
Generally follows adult dosing guidelines for those over 12 years, but titration should be cautious.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, but caution advised.
Severe:
Reduce maintenance doses by approximately 25% for patients with significant renal impairment (CrCl < 30 mL/min).
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed. Monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Reduce initial, escalation, and maintenance doses by approximately 25% for moderate impairment (Child-Pugh Class B).
Severe:
Reduce initial, escalation, and maintenance doses by approximately 50% for severe impairment (Child-Pugh Class C).
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that stabilizes neuronal membranes and inhibits the release of excitatory neurotransmitters (primarily glutamate and aspartate) by blocking voltage-sensitive sodium channels. This action prevents repetitive firing of neurons and reduces the propagation of seizure activity. It may also have effects on voltage-gated calcium channels and inhibit the release of serotonin and dopamine.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1.4 to 4.8 hours (oral)
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
0.97 to 1.36 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly reduced by enzyme-inducing AEDs (e.g., 13-14 hours) and prolonged by valproate (e.g., 48-59 hours).
Clearance:
Approximately 30 mL/min/kg (monotherapy)
ExcretionRoute:
Renal (approximately 94% as metabolites, 2% unchanged)
Unchanged:
Approximately 2%
Pharmacodynamics
OnsetOfAction:
Weeks (due to slow titration to minimize rash risk)
PeakEffect:
Weeks to months (after reaching maintenance dose)
DurationOfAction:
Related to half-life; effects persist as long as drug levels are maintained.
Safety & Warnings
BLACK BOX WARNING
Serious Skin Rashes: Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). The incidence of these rashes, which have resulted in death, is approximately 0.3% to 0.8% in pediatric patients (2 to 16 years of age) and 0.08% to 0.3% in adults. The risk of serious rash is increased by coadministration with valproate, exceeding recommended initial doses, or exceeding the recommended dose escalation for lamotrigine. Benign rashes are also common, but it is not possible to predict which rashes will prove to be serious. Therefore, lamotrigine should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful menstrual periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem (Hemophagocytic Lymphohistiocytosis)
This medication can cause a rare but life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Difficulty walking (new or worsening)
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor if they bother you or do not go away:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Sleep disturbances
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or experience any symptoms that concern you, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful menstrual periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem (Hemophagocytic Lymphohistiocytosis)
This medication can cause a rare but life-threatening immune system problem called hemophagocytic lymphohistiocytosis (HLH). If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Difficulty walking (new or worsening)
Other Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following symptoms, contact your doctor if they bother you or do not go away:
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Shakiness
Sleep disturbances
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or experience any symptoms that concern you, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new or worsening skin rash (especially if it spreads, blisters, or peels)
- Fever, chills, body aches
- Swollen glands (lymph nodes)
- Sore throat, mouth sores, or eye irritation
- Swelling in your face or tongue
- Unusual bruising or bleeding
- Yellowing of your skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- Signs of aseptic meningitis (headache, stiff neck, nausea, vomiting, sensitivity to light)
- Worsening depression, suicidal thoughts, or unusual changes in behavior or mood
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have or have had
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your medical history, including any health problems you have or have had
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. This will help ensure your safety and prevent potential interactions with other medications.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the medication.
Monitoring and Lab Tests
Regular blood tests are necessary to monitor your condition. Follow your doctor's instructions for scheduling these tests. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor. These substances may interact with your medication and increase the risk of adverse effects.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or behaviors. This risk may be higher in individuals with a history of suicidal thoughts or actions. If you experience any new or worsening symptoms, such as depression, anxiety, restlessness, or mood changes, contact your doctor immediately. If you have suicidal thoughts or attempts, seek medical attention right away.
Rare but Serious Brain Condition
This medication may increase the risk of aseptic meningitis, a severe brain condition. If you experience symptoms such as headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult your pharmacist.
Heart Conditions and Abnormal Heartbeats
If you have a history of abnormal heartbeats, heart failure, or other heart problems, discuss your condition with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with certain heart conditions.
Pediatric Use
When administering this medication to children, use caution, as the risk of certain side effects may be higher in pediatric patients.
Birth Control and Hormone-Based Medications
If you are taking birth control pills or other hormone-based medications, inform your doctor, as these medications may affect the levels of this medication in your body. The risk of side effects may be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based medications may not be effective in preventing pregnancy while taking this medication. Use an alternative form of birth control, such as a condom.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult your doctor to adjust your treatment plan as needed.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. This will help ensure your safety and prevent potential interactions with other medications.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the medication.
Monitoring and Lab Tests
Regular blood tests are necessary to monitor your condition. Follow your doctor's instructions for scheduling these tests. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor. These substances may interact with your medication and increase the risk of adverse effects.
Mental Health and Suicidal Thoughts
Like other medications used to treat seizures, this drug may rarely increase the risk of suicidal thoughts or behaviors. This risk may be higher in individuals with a history of suicidal thoughts or actions. If you experience any new or worsening symptoms, such as depression, anxiety, restlessness, or mood changes, contact your doctor immediately. If you have suicidal thoughts or attempts, seek medical attention right away.
Rare but Serious Brain Condition
This medication may increase the risk of aseptic meningitis, a severe brain condition. If you experience symptoms such as headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult your pharmacist.
Heart Conditions and Abnormal Heartbeats
If you have a history of abnormal heartbeats, heart failure, or other heart problems, discuss your condition with your doctor. Abnormal heartbeats can increase the risk of sudden death in individuals with certain heart conditions.
Pediatric Use
When administering this medication to children, use caution, as the risk of certain side effects may be higher in pediatric patients.
Birth Control and Hormone-Based Medications
If you are taking birth control pills or other hormone-based medications, inform your doctor, as these medications may affect the levels of this medication in your body. The risk of side effects may be increased during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based medications may not be effective in preventing pregnancy while taking this medication. Use an alternative form of birth control, such as a condom.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult your doctor to adjust your treatment plan as needed.
Overdose Information
Overdose Symptoms:
- Dizziness
- Blurred vision
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Decreased consciousness
- Coma
- Seizures
- Cardiac conduction abnormalities (e.g., QRS prolongation)
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is generally supportive; there is no specific antidote.
Drug Interactions
Major Interactions
- Valproate (valproic acid, divalproex sodium): Significantly increases lamotrigine levels (inhibits glucuronidation), requiring a substantial reduction in lamotrigine dose and slower titration to avoid severe rash.
- Oral Contraceptives (estrogen-containing): Can significantly decrease lamotrigine levels (induces glucuronidation), potentially leading to loss of seizure control or mood stabilization. Dose adjustments may be needed.
- Rifampin: Significantly decreases lamotrigine levels (potent enzyme inducer), requiring increased lamotrigine dose.
- Lopinavir/Ritonavir, Atazanavir/Ritonavir: Can decrease lamotrigine levels.
- Carbamazepine, Phenytoin, Phenobarbital, Primidone: Decrease lamotrigine levels (enzyme induction), requiring increased lamotrigine dose.
Moderate Interactions
- Paracetamol (acetaminophen): May slightly decrease lamotrigine levels with chronic high-dose use.
- Risperidone: Co-administration may lead to increased risperidone levels and decreased lamotrigine levels, though clinical significance is variable.
- Sertraline: May slightly decrease lamotrigine levels.
- Lithium: No significant pharmacokinetic interaction, but monitor for additive CNS effects.
Minor Interactions
- Bupropion: May slightly increase lamotrigine levels.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for rare but serious hematologic reactions (e.g., aplastic anemia, agranulocytosis).
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: To establish baseline and monitor for rare but serious hepatic dysfunction.
Timing: Prior to initiation
Renal Function Tests (Creatinine, BUN)
Rationale: To establish baseline and guide dosing in patients with renal impairment.
Timing: Prior to initiation
Skin Examination
Rationale: To document baseline skin condition and educate patient on rash symptoms.
Timing: Prior to initiation
Routine Monitoring
Clinical response (seizure frequency/severity, mood stability)
Frequency: Regularly during titration and maintenance
Target: Optimal seizure control with minimal side effects; stable mood.
Action Threshold: Increased seizure frequency, mood instability, or intolerable side effects warrant dose adjustment or re-evaluation.
Adverse effects (especially rash, fever, lymphadenopathy, facial swelling, mouth sores)
Frequency: Daily during initial titration, then regularly
Target: Absence of severe cutaneous adverse reactions (SCARs).
Action Threshold: Any signs of rash, fever, or systemic symptoms require immediate discontinuation and medical evaluation.
Drug levels (therapeutic drug monitoring)
Frequency: Not routinely recommended, but may be useful in specific situations (e.g., suspected non-adherence, drug interactions, renal/hepatic impairment, pregnancy, or lack of efficacy/toxicity at usual doses).
Target: Typically 3-14 mcg/mL for epilepsy, but clinical response is paramount.
Action Threshold: Levels outside expected range or inconsistent with clinical picture may prompt dose adjustment.
Symptom Monitoring
- Skin rash (especially blistering, peeling, or widespread)
- Fever
- Swollen lymph nodes
- Swelling of the face or lips
- Sore throat or mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe muscle pain or weakness
- Changes in vision
- Increased seizure frequency or severity
- Significant mood changes (worsening depression, suicidality, mania)
- Signs of aseptic meningitis (headache, stiff neck, nausea, vomiting, light sensitivity)
Special Patient Groups
Pregnancy
Lamotrigine is generally considered one of the safer antiepileptic drugs during pregnancy, particularly as monotherapy. However, it crosses the placenta. The decision to use lamotrigine during pregnancy should be made after careful consideration of the risks and benefits, as untreated epilepsy or bipolar disorder also poses risks to the mother and fetus. Dose adjustments may be needed during pregnancy due to changes in drug clearance.
Trimester-Specific Risks:
First Trimester:
Some studies have suggested a slightly increased risk of oral clefts (e.g., cleft lip/palate) with first-trimester exposure, particularly at higher doses or in combination with other AEDs, but more recent and larger studies have not consistently confirmed this or found the risk to be very low and comparable to the general population. Close monitoring is recommended.
Second Trimester:
No specific teratogenic risks identified beyond the first trimester. Monitor lamotrigine levels as clearance may increase, potentially requiring dose adjustments.
Third Trimester:
No specific teratogenic risks identified. Monitor lamotrigine levels as clearance may increase. Monitor neonate for potential withdrawal symptoms or signs of toxicity (e.g., sedation, poor feeding) if maternal levels were high at delivery.
Lactation
Lamotrigine is excreted into breast milk. While generally considered compatible with breastfeeding, infants should be monitored for adverse effects such as rash, sedation, poor feeding, or apnea. The infant's serum lamotrigine levels can be measured if concerns arise. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
Moderate risk (L3). Monitor for drowsiness, poor feeding, rash, or apnea. Some infants may have detectable serum levels.
Pediatric Use
Approved for partial seizures, generalized tonic-clonic seizures, and Lennox-Gastaut syndrome in patients 2 years and older. The risk of serious rash is higher in pediatric patients (especially under 16 years) compared to adults. Dosing is weight-based and requires careful, slow titration, especially when co-administered with valproate. Not recommended for children under 2 years due to insufficient data and higher rash risk.
Geriatric Use
Use with caution. Start with lower doses and titrate more slowly due to potential age-related decreases in renal and hepatic function, and increased sensitivity to adverse effects. Monitor for dizziness, ataxia, and sedation, which can increase fall risk.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rashes. Emphasize strict adherence to the dosing schedule.
- Educate patients thoroughly about the signs and symptoms of serious rash and the importance of immediate discontinuation and medical evaluation if they occur.
- Be aware of significant drug interactions, especially with valproate (requires lower lamotrigine dose) and oral contraceptives/enzyme-inducing AEDs (require higher lamotrigine dose).
- Lamotrigine levels can fluctuate significantly during pregnancy; therapeutic drug monitoring may be useful to guide dose adjustments.
- While not routinely monitored, lamotrigine levels can be helpful in cases of suspected non-adherence, drug interactions, or unexplained toxicity/lack of efficacy.
- Lamotrigine is effective for both depressive and manic symptoms in bipolar disorder, making it a valuable mood stabilizer, particularly for bipolar depression.
Alternative Therapies
- For Epilepsy: Levetiracetam, Carbamazepine, Oxcarbazepine, Valproate, Topiramate, Gabapentin, Phenytoin, Zonisamide, Lacosamide, Pregabalin, etc.
- For Bipolar Disorder: Lithium, Valproate, Carbamazepine, Quetiapine, Olanzapine, Lurasidone, Cariprazine, etc.
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 for generic 25mg x 30 tablets per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Generally Tier 1 or Tier 2 for generic formulations on most commercial and government insurance plans.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.